Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT01991769
Status:
COMPLETED
Last Update Posted:
2016-06-14
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial function', 'timeFrame': '24 hours', 'description': 'measured as flow mediated dilatation (FMD) of the brachial artery using high resolution vascular ultrasound according to current guidelines'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise', 'endothelium', 'postprandial period'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '26272328', 'type': 'RESULT', 'citation': 'Hollekim-Strand SM, Malmo V, Follestad T, Wisloff U, Ingul CB. Fast food increases postprandial cardiac workload in type 2 diabetes independent of pre-exercise: A pilot study. Nutr J. 2015 Aug 14;14:79. doi: 10.1186/s12937-015-0069-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function.\n\nBoth healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an unhealthy meal high in saturated fat and fast carbohydrates. The two different exercise training modes used are high intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise training in advance of an unhealthy meal will improve endothelial- and cardiac function in healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects on the endothelium more than MIT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy or type 2 diabetes\n\nExclusion Criteria:\n\n* type 2 diabetes more than 10 years\n* unstable angina\n* myocardial infarction\n* overt cardiovascular disease.\n* severe valvular disease.\n* overt lung disease.\n* orthopedical- /neurological restrictions\n* severe disease related to diabetes type 2 (neuropathy, micro-or macroalbuminuria, retinopathy)\n* body mass index \\>35\n* severe eating disorders.\n* personality disturbances.\n* planned surgery during the project period.\n* patients who achieve greater than the current exercise guidelines for type 2 diabetes (210 min/week) before the start of the study.\n* uncontrolled hypertension\n* kidney failure\n* cardiomyopathy\n* smoking\n* patients who probably not will be able to complete the study\n* alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT01991769', 'briefTitle': 'Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training', 'orgStudyIdInfo': {'id': '2011/1801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise diabetes type 2', 'description': "4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.", 'interventionNames': ['Behavioral: 47 min moderate intensity training', 'Behavioral: exercise healthy volunteers', 'Behavioral: control; no exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'exercise healthy volunteers', 'description': "4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.", 'interventionNames': ['Behavioral: 47 min moderate intensity training', 'Behavioral: exercise healthy volunteers', 'Behavioral: control; no exercise training']}], 'interventions': [{'name': '47 min moderate intensity training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['exercise diabetes type 2', 'exercise healthy volunteers']}, {'name': 'exercise healthy volunteers', 'type': 'BEHAVIORAL', 'armGroupLabels': ['exercise diabetes type 2', 'exercise healthy volunteers']}, {'name': 'control; no exercise training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['exercise diabetes type 2', 'exercise healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Forskningsposten, St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'ISB', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Charlotte B Ingul, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}